US drug regulator wants office in India

Posted Atlivemint.com

New Delhi/Hyderabad: The
US health department, along with its drug regulator,
wants to depute personnel to India’s proposed
pharmaceuticals watchdog, Central Drug Authority,
and establish a regional office here, as part of a
strategy to help monitor quality beyond their borders
and ensure imports of safe products into the world’s
largest economy.

Acknowledging that an increasing
proportion of food products, drugs, vaccines and medical
devices consumed by US citizens were manufactured
overseas, the US food and drug administration, or
FDA, is preparing a plan to set up regional offices,
hire independent inspectors and collaborate with their
counterparts in different countries for stricter implementation
of safety and quality norms.

The agency faced criticism
last year for slipping up on inspecting non-US drug
makers.

Such an arrangement, if
it materializes, could mean increased scrutiny on
Indian drug makers, who own the largest number of
FDA-approved manufacturing plants outside the US,
and also account for half of all approvals for drug
raw material called active pharmaceutical ingredients
and a quarter of formulation drug approvals.

“We are open to them
(the Indian government) bringing people down to Washington
and other places where FDA works and we have signalled
the willingness to even talk about having an FDA person
here,” US secretary of health and human services
Michael O. Leavitt told Mint.

The US and Indian governments,
he added, were still “in the early stages of
the conversation”.
Leavitt explained that having more US personnel abroad
was a “part of a general strategy, whose purpose
will be to help others understand where US’
standards are, build their own capabilities and facilitate
communication”.

As a sign of increasing
dependence on cheaper manufacturing overseas, US imported
$48.3 billion (Rs1.99 trillion then) in pharmaceutical
products in 2007 until end August, up from $42.3 billion
a year earlier.

Elaborating on the possibility
of US FDA having an India office, one among several
regional offices planned, the regulator’s commissioner
Andrew C. von Eschenbach said it was part of the rethinking
at the agency in tightening regulations for drugs,
medical devices and food.

“We have multilateral
and bilateral agreements in place but it is different
than having a US FDA presence outside of US on a continuous,
on going basis. We look to put at least five of these
kinds of opportunities around of the world,”
he said.

Leavitt and von Eschenbach
are touring India along with officials to meeting
government officials and drug makers.

Last week, the delegation
was in China, where it signed agreements mandating
food producers get their exports certified by local
authorities and comply with US standards on food safety.

Last year, Chinese exports
to the US of ingredients used to make pet food were
found to be contaminated by melamine, a prohibited
chemical used in making plastic. This led to one of
the largest animal food recalls in the US.

No similar agreement is
being sought with New Delhi, Leavitt said.
“We are not here because there is a problem.
We are here because there is a possibility,”
added von Eschenbach.

Calling the US proposal
a “good intention”, a Union health ministry
senior official pointed out differences between regulatory
arrangements in the two countries. “The involvement
with the US FDA will be better at a later stage when
we have the concept of dossier filing, stringent pharmacovigilance
and a patient information system,” the official
said, adding such a regime was yet to be formed in
India.

Dossier filing involves
detailed regulatory submissions on chemical composition,
efficacy, contra-indications and other minute details
of any chemical that goes into making a drug.

Most drugs sold in India
get approved based on such filings in the US or Europe,
which the office of the drug controller general of
India then investigates for its therapeutical equivalence.

Dossier filing is required
only for new drugs developed here in India, which
are very few in number and, so, not an area of expertise
of Indian drug regulators. Pharmacovigilance is the
monitoring of a drug for its efficacy and adverse
reactions once it has been introduced in the market.

The prospect of tighter
regulation is being welcomed, at least publicly, by
Indian drug makers and sector experts.

Says Cipla Ltd’s chief
executive officer Amar Lulla: “Today, even though
our sites might be FDA-approved, they have reservations
and cast a doubt on the quality” even if it
is unstated. Lulla added that a regional FDA office
will only enhance the credibility of regulation-compliant
drug makers as they will come under continuous watch.

The FDA and US health department
plan comes close on the heels of a recent US government
audit which pointed out that in a year, FDA inspected
just 7% of the drug makers outside the US that export
drugs to that country.

There are approximately
800 FDA investigators trained to conduct foreign inspections,
performing more than 200 foreign drug manufacturing
inspections a year.

Against this, there are
thousands of FDA-approved drug manufacturing facilities
globally. For the fiscal year to March 2007, FDA could
inspect 13 of 714 firms in China and 65 of 410 Indian
drug makers, according to the US government report.

With 906 approved API makers
in China and 400 in India, FDA is “logistically”
better off if it is to set up an office in the region,
Sanjiv Kaul managing director of private equity firm,
ChrysCapital Investment Advisors, said in a November
interview.

“Closer working with
FDA will only benefit the Indian drug companies as
they will cross over from a principal-agent relationship
to that of collaborators.”

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